510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895745Substantially Equivalent

Sickle Cell Solubility Test Kit

Simmler Inc, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895745 is the FDA 510(k) clearance record for SICKLE CELL SOLUBILITY TEST KIT, a class II device, cleared for Simmler, Inc. on under FDA product code JBB (Solubility, Hemoglobin, Abnormal). FDA records list 23 510(k) clearances for Simmler, Inc., from to . As of , FDA records show no recalls naming K895745.

Clearance record

Decision date
Received
(64 days to decision)
Product code
JBB Solubility, Hemoglobin, Abnormal
Regulation
21 CFR 864.7825
Device class
Class II
Review panel
Hematology
Applicant
Simmler, Inc. Post Office Box 25179, St. Louis MO
Third party review
No

Clearances, product code JBB

Trailing 12 months

FDA records hold no clearances under product code JBB in the trailing twelve months.

FDA records show no clearances under product code JBB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JBB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260